Rezafungin
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: HAFIZA AMNA QADEER
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Overview
Rezafungin is an echinocandin antifungal that is FDA approved for the treatment of of patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis.. Common adverse reactions include diarrhea, vomiting, nausea, abdominal pain, constipation, hypokalemia, hypomagnesemia, hypophosphatemia, pyrexia and anemia..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Rezafungin is indicated for the treatment of candidemia and invasive candidiasis. Administer the recommended dosage of Rezafungin once weekly by intravenous (IV) infusion, with an initial 400 mg loading dose, followed by a 200 mg dose once weekly thereafter. The safety of Rezafungin has not been established beyond 4 weekly doses. Rezafungin is administered by intravenous infusion over approximately one hour(~250ml/h).
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
The safety and effectiveness of Rezfungin have not been established in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Contraindications
Rezafungin is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.
Warnings
- Infusion Related Reactions
Infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, and chest tightness have been observed in clinical trials with REZZAYO. If these reactions occur, slow or pause the infusion and restart at a lower rate.
- Photosensitivity
Rezafungin may cause photosensitivity. Patients should be advised to use protection from sun exposure and other sources of UV radiation during Rezafungin treatment.
- Hepatic Adverse Reactions
In some patients with serious underlying medical conditions who were receiving multiple other medications along with Rezafungin, clinically significant hepatic abnormalities have occurred. Monitor patients who develop abnormal liver tests during Rezafungin therapy and evaluate patients for their risk/benefit of continuing Rezafungin therapy.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Rezafungin Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Rezafungin Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Rezafungin Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Rezafungin in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Rezafungin in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Rezafungin during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Rezafungin in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Rezafungin in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Rezafungin in geriatric settings.
Gender
There is no FDA guidance on the use of Rezafungin with respect to specific gender populations.
Race
There is no FDA guidance on the use of Rezafungin with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Rezafungin in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Rezafungin in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Rezafungin in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Rezafungin in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Rezafungin Administration in the drug label.
Monitoring
There is limited information regarding Rezafungin Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Rezafungin and IV administrations.
Overdosage
There is limited information regarding Rezafungin overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Rezafungin Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Rezafungin Mechanism of Action in the drug label.
Structure
There is limited information regarding Rezafungin Structure in the drug label.
Pharmacodynamics
There is limited information regarding Rezafungin Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Rezafungin Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Rezafungin Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Rezafungin Clinical Studies in the drug label.
How Supplied
There is limited information regarding Rezafungin How Supplied in the drug label.
Storage
There is limited information regarding Rezafungin Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Rezafungin |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Rezafungin |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Rezafungin Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Rezafungin interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Rezafungin Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Rezafungin Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.